The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.
Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment,” said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”
Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds.
The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive Kybella or a placebo for up to six treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo.
Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area.
Kybella should not be used outside of the submental area, and it should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.
Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product.
Consumers and health care professionals are encouraged to report adverse reactions from the use of Kybella to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-FDA-1088.
Kybella is manufactured by Kythera Biopharmaceuticals Inc. based in Westlake Village, California.
Posted on the FDA website on 29 April 2015